Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT04601012
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2020-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography.', 'timeFrame': 'one month', 'description': 'The parameter analyzed by optical coherence tomography angiography was: retinal vessel density'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.', 'detailedDescription': 'To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19.\n\nThe optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 18 years with previous diagnosis of COVID-19. They did not present other ophthalmological diseases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 18 years\n* diagnosis of previous COVID-19\n* absence of previous ocular surgery, congenital eye disease, high myopia (\\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.\n* absence of significant lens opacities, low-quality OCT and OCT-A images.\n\nExclusion Criteria:\n\n* age younger than 18 years\n* absence of previous diagnosis of COVID-19\n* presence of previous ocular surgery, congenital eye disease, high myopia (\\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.\n* presence of significant lens opacities, low-quality OCT and OCT-A images.'}, 'identificationModule': {'nctId': 'NCT04601012', 'briefTitle': 'OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study', 'orgStudyIdInfo': {'id': '2020/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COVID19', 'description': 'The patients with previous diagnosis of COVID19', 'interventionNames': ['Diagnostic Test: Optical coherence tomography angiography']}, {'label': 'Control subjects', 'description': 'Healthy subjects without actual and previous ocular diseases', 'interventionNames': ['Diagnostic Test: Optical coherence tomography angiography']}], 'interventions': [{'name': 'Optical coherence tomography angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.', 'armGroupLabels': ['Control subjects', 'Patients with COVID19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples "Federico II"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Gilda Cennamo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}